High-risk, or class III, devices — those which support or sustain human life, prevent impairment of human health, or present a potential, unreasonable risk of illness or injury—are generally reviewed via the premarket approval PMA process [ 20 ]. Total knowledge score is estimated by adding the individual scores of each response.
However, recent studies examining the process have raised concerns about the quality of data that FDA experts consider when they review PMA applications [ 6 — 8 ]. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated.
The quality of knowledge was one of the neglected features among job profile of Anganwadi workers. The mean knowledge score about various ICDS services is about The FDA has been working to update device classifications to prevent high-risk devices from gaining approval via the substantial equivalence standard, so fewer such devices should be on the US market in the future [ 21 ].
Anganwadi centre is the central point for the delivery of services at community levels to children below six years of age, pregnant women, nursing mothers and adolescent girls. Medium-risk, or class II, devices e. Frequent interactions among Anganwadi workers and supervisors should be introduced for imparting information and awareness.
These recalls underscore the importance of device regulation in protecting patient safety as well as the need for clinicians to understand the evidence supporting FDA approval of specific device technologies. The FDA was granted permission to request from a device manufacturer any data it considered relevant to providing reasonable assurance of safety and effectiveness.
This record will be updated as the status changes.